Finding Of No Significant Impact Research Articles

Capitalism and the Commodification of Salmon: From Wild Fish to a Genetically Modified Species

On February 25, 2013, the U.S. Food and Drug Administration (FDA) closed the public comment period for the environmental assessment of the AquAdvantage Salmon. Their review of the first genetically modified animal for human consumption concluded with a “finding of no significant impact.” Numerous fishermen, consumer safety advocates, public health officials, ecologists, and risk assessment experts submitted comments that directly challenged this finding. Despite the opposition, it is very likely that the FDA’s approval of this genetically engineered salmon and precedent-setting regulatory process is imminent.… The aquaculture industry and corporate investors are championing this recent development in food biotechnology. They propose that this “invention” will yield ecological benefits, such as preserving wild salmon, while enhancing efficiency.… Unfortunately, the discussion of fisheries and oceans is constrained by ideological justifications that prevent a comprehensive assessment.… [The alternative approach presented here focuses on] how the logic of capital has shaped production and commodification processes. It also highlights how the most recent case of biotechnology in relation to salmon serves the needs of capital by increasing control of biological and ecological systems in order to better conform to economic dictates. The genetic modification of salmon is part of a biological speedup, whereby natural processes are transformed to achieve faster rates of return in the food marketplace.This article can also be found at the Monthly Review website, where most recent articles are published in full.Click here to purchase a PDF version of this article at the Monthly Review website.

AquAdvantage® Salmon - a pioneering application of biotechnology in aquaculture

The U.S. FDA is currently reviewing AquaBounty Technologies' New Animal Drug Application for a fast growing transgenic Atlantic salmon, known as AquAdvantage® Salmon, which would be the first genetically modified food animal approved for human consumption. AquAdvantage® Salmon was developed by inserting into a fertilized Atlantic salmon egg, a transgene constructed from the growth hormone gene of a related species (Chinook salmon). The AquAdvantage® genetic construct confers upon the Atlantic salmon a rapid growth phenotype and improved metabolic efficiencies associated with low but sustained levels of growth hormone. This allows the fast growing AquAdvantage® Salmon to reach market size in half the time of a conventional Atlantic salmon. AquAdvantage® Salmon will be available only as all female, sterile, eyed eggs, and the resulting fish must be maintained in a freshwater, land based, physically contained facility [1]. The founding line of AquAdvantage® Salmon was created in 1989, and an Investigational New Animal Drug (INAD) dossier was opened with the FDA in 1995. In 2009, AquaBounty submitted to the FDA the last of more than 25 scientific studies in support of our application. In 2010 the FDA presented their findings to the Veterinary Medical Advisory Committee (VMAC), and recommended an approval. The VMAC committee, comprised of independent experts selected from academia, industry, and NGO's, concurred with the FDA's findings, which were that AquAdvantage® Salmon is equivalent to conventional farmed Atlantic salmon, and is safe for human consumption as well as safe for the environment. The regulatory analysis included an environmental assessment of a proposed AquAdvantage® Salmon egg production site in Canada, and an AquAdvantage® Salmon growout site in Panama, both of which were inspected and approved by the FDA. Important biosecurity elements for containing AquAdvantage® Salmon and minimizing potential risk to the environment at the two production sites include physical, biological, and environmental containment. For example, at the proposed growout site in Panama which is more than 120 km from the nearest ocean, sterile, all female populations of AquAdvantage® Salmon are confined to a highly biosecure culture facility possessing 21 individual containment elements, with a minimum of eleven containment barriers in sequence. In addition to the biological and physical containment elements, a natural thermal barrier of lethally high water temperatures (for Atlantic salmon) downstream of the facility would effectively prevent any live, escaped AquAdvantage® Salmon from reaching the Pacific Ocean. In 2012 the FDA published the environmental assessment for public commentary, and a Finding of No Significant Impact (FONSI), indicating that rearing AquAdvantage® Salmon in those sites did not present a risk to the environment when reared under the conditions of use stipulated by the FDA. The public comment period concluded in April of 2013, and a final resolution of the application is expected this year from the FDA. If approved by the FDA, the product offered by AquaBounty would be eyed eggs of AquAdvantage® Salmon, which would carry an FDA approved label indicating that they are female, triploid, genetically engineered Atlantic salmon eggs carrying a single copy of the AquAdvantage®gene construct. The label would also stipulate that the fish from these eggs could only be grown in pre-approved, land based, physically contained, freshwater aquaculture facilities. As a pioneering application for a genetically modified animal destined for human consumption, AquAdvantage® Salmon has attracted considerable attention and opposition by anti-GMO, anti-biotech activist organizations, as well as the organic food industry which is threatened by the more productive, lower cost, food production alternatives offered by GM plant and animal biotechnology. Resigned to accepting the inevitable regulatory approval of GM salmon and other innovative animal biotech products, the anti-GMO community is now desperately resorting to labeling initiatives, and economic extortion of future market stakeholders, in an effort to commercially stigmatize genetically modified food products.

GUIDELINES FOR THE REGULATION OF GENETICALLY ENGINEERED ANIMALS

The FDA has been regulating genetically engineered (GE) animals under the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act or the Act) since producers of these animals first approached the agency in the mid-1990s, although it did not issue a final Guidance for Industry clarifying its statutory authority until 2009 (Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs: http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM113903.pdf). The regulatory trigger that enables the regulation of these animals under the new animal drug provisions of the Act is the definition of a drug as “an article (other than food) that is intended to affect the structure or any function of the body of man or other animals.” The products of modern biotechnology (such as spliced recombinant DNA) are technically the “articles” that must be approved, but for shorthand, we often refer to the regulation of “genetically engineered” animals. For the purpose of the guidance, FDA defined “genetically engineered (GE) animals” as those animals modified by rDNA techniques, including all progeny that contain the modification. The term GE animal can refer both to an animal with a heritable rDNA construct or its residues and to an animal with a nonheritable rDNA construct (e.g. a construct intended as therapy for a disease in that animal). If the agency engages in an “action,” such as an approval, obligations under the National Environmental Policy Act (NEPA) are triggered, such that the agency must perform an environmental assessment to determine whether a significant impact is likely to occur on the environment of the United States. If not, the agency issues a Finding of No Significant Impact (FONSI). If a significant impact is likely to occur as the result of an agency action, the agency must engage in a more complex process to characterise that impact in an Environmental Impact Statement (EIS). This regulation is consistent with the Coordinated Framework for the Regulation of Biotechnology, a policy that was first issued by issued by the Office of Science and Technology Policy [51 Fed Reg 23,302 (1986)] of the United States Government. It describes the interagency mechanism for “sharing scientific information related to biotechnology,” and states that, to the extent possible, jurisdiction of the products of biotechnology lies with a single agency. Where more than one agency will review a particular product, “the policy establishes a lead agency and consolidated or coordinated reviews.” Consistent with this policy, FDA has leveraged, and intends to continue to leverage, the expertise of other agencies in the review of GE animal-related applications. Under certain conditions, based on risk, the agency may not enforce the premarket approval requirement for some GE animals. In general, these include GE animals of non-food species that are regulated by other government agencies or entities, such as GE animals of non-food species that are raised and used in contained and controlled conditions such as GE laboratory animals (e.g. mice, rats, some model fish) used in research institutions. In addition, on a case-by-case basis, the agency may consider exercising enforcement discretion for GE animals of very low risk, non-food species GE animals, such as the Zebra danio aquarium fish genetically engineered to fluoresce in the dark (GloFish). An exemption from the prohibition on introducing an unapproved new animal drug in interstate commerce is provided for in the regulations covering “investigations,” which allow for lawful research to occur, including the shipping of GE animals or their gametes from the sponsor of an investigation to other qualified investigators. These and other responsibilities are outlined in GFI 187, as are recommendations for the submission of data to be reviewed by CVM’s hierarchical risk-based review, and will be the subject of this talk.

Research Article: Assessing Cumulative Significance of Greenhouse Gas Emissions: Resolving The Paradox—The Sphinx Solution

The United States courts are increasingly requiring federal decision-makers to assess greenhouse gas emissions of proposed actions in National Environmental Policy Act (NEPA) analyses. With respect to NEPA, the cumulative effect of a proposal must be assessed in reaching a determination regarding the significance of its environmental impact. Analysis of cumulative impacts is one of NEPA's most challenging requirements. The problem of assessing cumulative greenhouse gas emission (GHG) impacts under NEPA is one of the thorniest in American environmental law and poses perhaps the most significant challenge to NEPA's regulatory framework in decades. A strict regulatory interpretation of “significance” can also lead to a paradox (Eccleston's Cumulative Impact Paradox), when one considers how the environment appeared before the intervention of human activities. A Finding of No Significant Impact (FONSI), by its very definition, states that an action will not have a significant effect, including a cumulatively significant effect. Because the global GHG concentration is generally considered to have already breached a cumulatively significant level (i.e., cumulatively significant impact), the assessment of proposals that emit even innocuous levels of GHGs can become a paradoxical effort. Specifically, a logical paradox arises in which many, if not most, federal activities should require preparation of an environmental impact statement (EIS) because they are technically ineligible for a FONSI. A strict interpretation of “significance” leads to such a conclusion, even in cases where the direct and indirect impacts of a relatively ‘small’ proposed activity may be finite but essentially innocuous. As described in this article, NEPA practitioners and decision-makers are beginning to appreciate the implications of this Cumulative Impact Paradox. This paradox must be resolved, if the analysis of cumulative GHG emissions is to contribute in a meaningful way to federal decision making.

Finding of No Significant Impact (APHIS Permit 05-354-01r)

Biotechnology Law ReportVol. 26, No. 5 TextsFinding of No Significant Impact (APHIS Permit 05-354-01r)Published Online:9 Jan 2008https://doi.org/10.1089/blr.2007.9895AboutSectionsPDF/EPUB Permissions & CitationsPermissionsDownload CitationsTrack CitationsAdd to favorites Back To Publication ShareShare onFacebookTwitterLinked InRedditEmail "Finding of No Significant Impact (APHIS Permit 05-354-01r)." , 26(5), pp. 521–522FiguresReferencesRelatedDetails Volume 26Issue 5Oct 2007 InformationMary Ann Liebert, Inc.To cite this article:Finding of No Significant Impact (APHIS Permit 05-354-01r).Biotechnology Law Report.Oct 2007.521-522.http://doi.org/10.1089/blr.2007.9895Published in Volume: 26 Issue 5: January 9, 2008PDF download

Commentary: Applying the Significant Departure Principle in Resolving the Cumulative Impact Paradox: Assessing Significance in Areas That Have Sustained Cumulatively Significant Impacts

The National Environmental Policy Act (NEPA) of 1969 implementing regulations require an assessment of cumulative impacts in reaching a determination regarding the potential significance of impacts associated with a proposed action. Analysis of cumulative impacts is one of NEPA's most challenging and complex requirements. With respect to the assessment of cumulative impacts, a strict regulatory interpretation of “significance” can lead to a paradox (the Cumulative Impact Paradox, or “Paradox”). A Finding of No Significant Impact (FONSI), by its very definition, states that an action will not result in a significant effect, including a cumulatively significant impact. But because many environmental resources have already sustained significant cumulative impacts, a logical paradox can arise in which a strict interpretation of the regulatory requirements leads to the conclusion that many federal activities are technically ineligible for FONSIs and therefore require preparation of Environmental Impact Statements. A strict interpretation of “significance” can lead to such a conclusion, even in cases where the direct and indirect impacts of the proposed activity may be relatively nonsignificant. This Paradox must be resolved, if the analysis of cumulative impacts is to be practically and effectively integrated into federal decision making. This article presents a method or tool referred to as the Significant Departure Principle for resolving the aforementioned Paradox. Emphasis is placed on assessing environmental resources that have already sustained cumulatively significant impacts.

News Feature: US agency finds seismic operations have no significant impact on marine mammals

Abstract It’s the outcome that the oil industry had been hoping for. A major environmental impact assessment by the US Department of Interior’s Minerals Management Service (MMS) has concluded that seismic survey operations in the Gulf of Mexico do no discernible harm to marine mammal life. We summarise here some of the key points from the findings, the implications of which may reverberate beyond US offshore activities. In announcing the completion of an environmental assessment (EA) evaluating the potential environmental impacts of geological and geophysical (G&G) activities in the Gulf of Mexico, the Minerals Management Service (MMS) said that the best available information on the effects of seismic surveys on marine resources was analyzed, and in particular marine mammals, including sperm whales. Hundreds of documents were reviewed from around the world. The activities taken into account in the EA include seismic surveys, deeptow side-scan surveys, electromagnetic surveys, geological and geochemical sampling, and remote-sensing surveys which are used extensively to support oil and gas exploration in the Gulf of Mexico. The impact-producing factors considered in the EA included seismic survey noise, vessel and aircraft noise, seafloor disturbance, and space-use conflicts with seismic arrays. Each year there are about 20 MMS-permitted 3D seismic surveys conducted in the Gulf of Mexico. The conclusion of the EA was that G&G activities are not expected to result in significant adverse impacts to any of the potentially affected resources. Potentially adverse but not significant impacts were identified for marine mammals, except the manatee, for which negligible impacts were identified. As a result, MMS has issued a ‘Finding of No Significant Impact.’ The EA will be included as part of an information package used by MMS in the near future to petition the National Oceanic and Atmospheric Administration (NOAA). This petition will request NOAA to issue regulations to allow small ‘takes’ incidental to seismic surveys in the Gulf of Mexico, under the enabling regulations of the Marine Mammal Protection Act. The MMS currently requires operators engaged in activities on the US Outer Conbtinental Shelf (OCS), including G&G activities, to comply with a number of lease stipulations, Notices to Lessees, and other mitigation measures designed to reduce or eliminate impacts to sensitive environmentalresources from impact-producing factors such as vessel or aircraft traffic, anchoring, and trash and debris. These mitigation measures are required under the OCS Lands Act, the Endangered Species Act, and the Marine Mammal Protection Act to ensure environmental protection, consistent environmental policy, and safety. As part of the impact analyses completed in the G&G EA, current protective and mitigation measures were evaluated (Alternative 1). Additional feasible mitigation measures were also considered (Alternatives 2 and 3), as were potential restrictions on concurrent operations within close proximity to one another (Alternative 4), as viable alternatives to further reduce the potential for impacts to marine mammals. The PEA reviewed G&G activities which were the subject of a previous Environmental Impact Statement (EIS) prepared by the US Geological Survey in 1976 and a PEA prepared by the MMS in 1984. A new PEA was needed in light of advances in G&G technology, expansion of activities into deep offshore waters, and improved knowledge of acoustic impacts on marine life. Further, those G&G activities that were previously determined to be categorical exclusions (CATEXs), exempt from detailed analysis (based on previous environmental documents), needed to be revisited and re-evaluated.

Environmental regulatory compliance on army lands: A case study

A “finding of no significant impact” (FONSI) resulting from an environmental assessment (EA) was reported by the US Army in June 1986 for the construction and utilization of a multipurpose range complex (MPRC) at the Pohakuloa Training Area, Hawaii. There was little public response, and the US Fish and Wildlife Service and state agencies were consulted and had few comments concerning the results of the botanical surveys used in the assessment. Construction of the $24 million project was begun in 1988. Near the end of construction in 1989 a lawsuit was filed to halt construction because an environmental impact statement (EIS) had not been done for the project, and the plaintiff thought that significant damage had occurred to several unusual ecosystems. Judgment was against the plaintiff and construction continued. An appeal was filed with the 9th Circuit Court. As MPRC construction was nearly complete, and on advice of Department of Justice lawyers, the Department of Army agreed to settle out of court. The settlement in part called for: (1) the plaintiff to drop the appeal and allow construction to be completed as scheduled, and (2) the Department of Army to prepare an EIS for the operation of the MPRC. A subsequent botanical survey for the EIS discovered one endangered plant species, four category 1 candidate plant species (taxa with sufficient data to support listing as endangered or threatened), three category 2 candidate plant species (taxa with some evidence of vulnerability but insufficient data to support listing at this time), one category 3a species (presumably extinct taxa), and possibly three undescribed species growing within the MPRC boundary. The MPRC case study is an excellent example of why the National Environmental Policy Act (NEPA) must be modified to require in-depth and thorough environmental surveys.

From proposal to decision: Suggestions for tightening up the “NEPA process”

Although the process of documenting compliance with NEPA (the National Environmental Policy Act) requires no drastic revisions, it can be managed more rigorously. Suggestions for revision can be grouped under five major steps: 1) getting a complete proposal from the applicant; 2) getting the decision-making process onto the right decision-making path; 3) modifying the applicant's proposal 4) going down a shorter path through the EA/FONSI (environmental assessment and finding of no significant impact) or through categorical exclusion review; and 5) going down the longer path through the EIS. Step 2 is perhaps the most critical, because there a decision must be made whether to write an EA/FONSI or an EIS, on the basis of whether the proposal would “significantly affect … the … environment.” In the past, this decision has not always been made promptly or rigorously. Accordingly, we suggest that the agency responsible for NEPA compliance should develop a system (a “black box”), consisting of a core group of specialists working with an interdisciplinary team, using sophisticated techniques for modeling impacts and directing both their research and their writing according to the concept of significance. By determining more efficiently and reliably whether the impacts of a proposal would be significant, such an approach would improve management of the total process.